A Study to Evaluate Rucaparib in Combination With Nivolumab in Patients With Selected Solid Tumors (ARIES)

pharmaand

Status and phase

Terminated

Phase 2

Conditions

Endometrioid Adenocarcinoma

Epithelial Ovarian Cancer

Primary Peritoneal Carcinoma

High Grade Serous Carcinoma

Fallopian Tube Cancer

Treatments

Drug: Rucaparib

Drug: Nivolumab

Study type

Interventional

Funder types

Industry

Identifiers

NCT03824704

CO-338-097

Details and patient eligibility

About

This is an open label Phase 2, 2-stage, 2-cohort study to evaluate rucaparib in combination with nivolumab in patients with high-grade serous or endometroid ovarian cancer.

Patients entering the following cohorts must have BRCA mutational status confirmed by a central lab:

Cohort A1: No BRCA mutation in tumor; high level of LOH (loss of heterozygosity)
Cohort A2: BRCA mutation in tumor

Enrollment

1 patient

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

General Inclusion Criteria:

≥ 18 years of age
Adequate organ function
Life expectancy ≥ 16 weeks
Women of childbearing potential must have a negative serum pregnancy test
High-grade serous or endometrioid epithelial ovarian, fallopian tube, or primary peritoneal cancer
Received 1 or 2 prior regimens, including ≥ 1 prior platinum-based therapy and have platinum-sensitive disease
Relapsed/progressive disease (confirmed by radiologic assessment)
Willing and able to have a biopsy of tumor at screening and after 4 weeks of treatment.
Measurable disease (RECIST v1.1)- Cohort A1 only
ECOG performance status of 0 to 1

General Exclusion Criteria

Active second malignancy
Central nervous system brain metastases
Evidence of interstitial lung disease, active pneumonitis, myocarditis, or history of myocarditis.
Active, known or suspected autoimmune disease (eg, autoimmune hepatitis).
Condition requiring systemic treatment with either corticosteroids
Prior treatment with a PARP inhibitor or immune checkpoint inhibitor.
Non-epithelial tumors (pure sarcomas) or ovarian tumors with low malignant potential (ie, borderline tumors) or mucinous tumors. Mixed Mullerian tumors/carcinosarcomas are allowed.